Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions

Recruiting

• Conditions: Aortic Dissection; Aortic Root Aneurysm; Minimally Invasive Surgical Procedures
• Interventions: Procedure: Minimally invasive Bentall procedure

• Registration Number: NCT06177548
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

This study intends to include patients who had aortic root lesions and were treated with Bentall surgery from January 2019 to July 2023 in the First Affiliated Hospital of Xi'an Jiaotong University. The patients will be divided into the minimally invasive group and control group according to the surgical methods: the former underwent minimally invasive Bentall surgery through a small right intercostal incision; the latter underwent traditional Bentall surgery through a median sternal incision. By comparing the clinical data of patients in two groups, we will investigate the effect and safety of minimally invasive Bentall surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-11
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2024-10-25
• Study Completion: 2024-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Patients who were diagnosed with aortic root lesions and treated with the Bentall procedure at the First Affiliated Hospital of Xi'an Jiaotong University from January 2019 to July 2023 will be included in this study.

Exclusion Criteria

• Previous sternotomy or aortic root surgery;
• Combined coronary artery disease requiring simultaneous coronary revascularization;
• Combined aortic arch lesions requiring simultaneous aortic arch surgery;
• Preoperative comorbidities with severe single or multiple organ failure;
• Incomplete clinical information;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimally invasive Group	Minimally invasive Bentall procedure	Patients who underwent minimally invasive Bentall procedure will be included. The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.

Primary Outcome Measures

Name	Time	Method
30-day mortality rate	1-month after the operation.	It focuses on the mortality rate of all patients after the operation after 30 days. The data will be obtained from medical records.

Secondary Outcome Measures

Name	Time	Method
Mortality rate during hospitalization	About 10 days after the operation.	It focuses on the mortality rate of all patients after the operation during hospitalization. The data will be obtained from medical records.
Postoperative ICU length of stay	About 3 days after the operation.	It focuses on the ICU length of stay of all patients after the operation. The data will be obtained from medical records.
Blood transfusion volume during hospitalization	About 10 days after the operation.	It focuses on the blood transfusion volumes of all patients after the operation during hospitalization. The data will be obtained from medical records.
Postoperative ventilation time	About 1 day after the operation.	It focuses on the postoperative ventilation time of all patients after the operation. The data will be obtained from medical records.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiantong University; 🇨🇳 Xi'an, Shaanxi, China